Person Responsible for Regulatory Compliance (PRRC)
Mandatory EU MDR & IVDR requirement
To sell products in the EU market, manufacturers of medical devices and IVDs must officially designate a PRRC. Without an officially designated PRRC, companies cannot market their products in the EU.
What is a PRRC?
To sell products in the EU market, manufacturers of medical devices and/or IVDs must officially designate a PRRC (Person Responsible for Regulatory Compliance). This role is a mandatory requirement under the EU MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation).
Without an officially designated PRRC, companies cannot market their products in the EU.
Small and micro companies (fewer than 50 employees and annual turnover and/or balance sheet <€10M) often struggle to hire qualified RAQS resources due to limited availability and high costs. Outsourcing this service to our QbD experts provides an efficient solution.
How can we support you?
We provide tailored PRRC services based on your needs:
PRRC for Medical Devices
Act as your PRRC for small or micro enterprises. Consult on regulatory requirements for PRRC designation and tasks. Assist in writing or reviewing procedures related to PRRC responsibilities.
PRRC for IVDs
Act as your PRRC for small or micro enterprises. Act as the PRRC for the EU Authorized Representative, ensuring their obligations under the regulatory mandate are fulfilled. Consult on requirements and assist with procedures.
Regulatory consultation
Expert consultation on regulatory requirements for PRRC designation and related tasks across both MD and IVD sectors.
Procedure support
Assistance in writing or reviewing procedures related to PRRC responsibilities, ensuring compliance with MDR and IVDR.
Responsibilities of a PRRC
• Review the Quality Management System (QMS) and technical documentation before products reach the market
• Be notified of audits, QMS/product changes, complaints, recalls, or field safety actions
• Be permanently and continuously available to the company
Why QbD Group
Your trusted partner
To ensure easy access to the European market, it is important to choose an experienced person responsible for regulatory compliance (with at least four years of professional experience in regulatory affairs or in quality management systems related to medical devices) who can guide you through the process.
QbD Group's experts can act as your outsourced PRRC, helping your company comply with EU regulations for medical device and IVD manufacturers.
With over 20 years of industry experience, we can guarantee you the benefit of an outsourced center of excellence for all quality & regulatory matters, in a cost-effective manner.
The process for designating a QbD Group PRRC is well structured and is based on the intensive involvement of the QbD Group designated person for the PRRC service in the company's processes.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.